Compounded bioidentical formulations are often described as "custom" recipes of hormone formulations prepared by a pharmacist following an individual prescriber's order for a specific patient.  Compounded hormone products are not governed with the same type of oversight as commercial bioidentical estrogens that have been FDA-approved so they have not been tested for purity, potency, efficacy or safety.   Bioidentical estrogens that are FDA-approved have been tested according to specific protocols to ensure that they meet stringent guidelines for consistency.  Bioidentical estrogen that is FDA-approved is often also covered by many insurance plans or other patient saving programs.  Women should review their insurance coverage and discuss their options with a healthcare professional.

Traditional compounding is used to prepare medications in such instances as when a patient is allergic to an inactive ingredient in a commercially available product or requires an alternate form of administration. The FDA recognizes the need for this practice, but women should be aware that compounded drugs or formulations are not FDA-approved or tested for quality and potency.

"The bottom line is that if a woman wants to use bioidentical hormones to treat hot flashes from menopause, she should consider the fact that all FDA-approved non-oral estrogen products are also bioidentical and are tested for purity and consistency batch after batch," said Dr. Pollycove.

SOURCE Upsher-Smith Laboratories, Inc.